Actively Recruiting
Safety and Effectiveness of Decellularized Femoral Artery Allograft for Hemodialysis Access in End-Stage Renal Disease: A Multi-center Prospective Registry Study
Led by LifeNet Health · Updated on 2025-04-02
100
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing the safety and effectiveness of a decellularized human femoral artery allograft called Nexeon AVX for creating vascular access in patients with End-Stage Renal Disease (ESRD) who require hemodialysis. This prospective, observational post-market registry study aims to gather real-world data on this novel allograft's use in hemodialysis access. Participants will receive the Nexeon AVX allograft as part of their vascular access for hemodialysis. The study is open-label and involves patients with ESRD who need dialysis access where placement of an arteriovenous access graft is suitable. There are no comparator groups since this is an observational registry tracking outcomes after graft placement. During the study, participants will undergo ultrasound evaluations over 24 months to monitor the functional patency of the allograft. Researchers will collect safety and efficacy data, including additional secondary outcomes over the same duration. Participants are expected to return for scheduled assessments, and data will be collected to evaluate the graft's performance and any safety concerns over the two-year period.
CONDITIONS
Brief Title
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be male or female aged 18 years or older at the time of graft placement
- Have a diagnosis of End-Stage Renal Disease or kidney dysfunction requiring hemodialysis
- Need dialysis access to start or maintain dialysis where an arteriovenous graft is a suitable option
- Be able to understand the study, provide written informed consent, and agree to follow study requirements
- Have provided written authorization for use and disclosure of protected health information
You will not qualify if you...
- Currently participating in another investigational drug or device study
- Known sensitivity to processing reagents used in the graft manufacturing, including certain antibiotics and chemicals
- History or evidence of severe heart disease, recent heart attack within 6 months, dangerous heart rhythms, or unstable angina needing ongoing treatment
- History or evidence of severe peripheral vascular disease in the upper limbs
- Unable or unwilling to follow the study visit schedule
- Any condition that the investigator believes poses undue risk or may affect study data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure at enrollment
Participants receive a decellularized human femoral artery allograft to create vascular access for hemodialysis.
1 visit (in-person) for graft placement
Duration - Up to 24 months
Participants are monitored for up to 24 months to assess the safety and effectiveness of the allograft through ultrasound evaluations of graft patency.
Periodic visits for ultrasound evaluations up to 24 months
Trial Site Locations
Total: 4 locations
1
Infirmary Heath
Mobile, Alabama, United States, 36607
Actively Recruiting
2
Olive View - UCLA Medical Center
Sylmar, California, United States, 91342
Actively Recruiting
3
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
4
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
K
Kimberly Dorsch
M
Monique Alston-Epps
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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